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Completed

NCT Number: NCT05014932

Evaluation of Noise Induced by Ceramic-ceramic Friction Torques of Total Hip Prostheses With Customized Femoral Stem

Evaluation of noise induced by ceramic-ceramic friction torques of total hip prostheses with customized femoral stem.

Retrospective and prospective multicentric study.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Maussins-Nollet

Paris, 75019, France

About this study

On a series of patients operated on for more than two years after a total hip arthroplasty that resulted in the implantation of a ceramic-on-ceramic prosthesis with a customized femoral stem:

Primary objective: To assess the frequency of occurrence of joint noise.

Secondary objectives:

  • To describe the characteristics of the noise nuisance (date of onset, frequency, intensity, impact...)
  • To evaluate the individual and surgical factors associated with the occurrence of noise pollution.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient aged 18 years or older, who has been informed of the research
  • Patient who has had a fourth generation ceramic/ceramic hip replacement implanted for at least two years as a first-line replacement
  • Patient who has had a three-dimensional preoperative examination leading to the design and implantation of a custom femoral stem
  • Patient regularly monitored since surgery and for whom all clinical and radiological data are available at the three-month and two-year follow-up visits

Exclusion criteria

  • Patient operated for revision
  • Patient under legal protection, guardianship or curators
  • Patient who has indicated his opposition to the use of his medical data (by completing and returning the non-opposition form which will be sent to him)

Treatment and study plan

Primary outcomes

  1. Noise nuisance

    Time frame: 2 years

    Percentage of occurrence of noise nuisance (assessed in relation to the total number of patients and the total number of prostheses).

    The frequency of occurrence of noise nuisance will be analysed descriptively. The time elapsed until the occurrence of the noise nuisance will be additionally assessed by a Kaplan-Meier analysis.

Secondary outcomes

  1. Oxford Score

    Time frame: 2 years

    The Oxford Hip Score questionnaire (OHS 12) consists of 12 questions. It measures pain (6 items) and hip function (6 items) in relation to activities of daily living such as walking, dressing and sleep disturbance. Each question has 5 possible answers. Each has a value from 0 to 4, with 0 representing the highest level of severity and 4 representing no or almost no symptoms.

  2. Hip disability and Osteoarthritis Outcome Score (HOOS) Score

    Time frame: 2 years

    The HOOS questionnaire is a self-administered questionnaire specific to hip arthroplasty. It consists of 40 questions with 5 domains: 5 questions on symptoms and stiffness; 10 questions on pain; 17 questions on functional results in daily life; 4 questions on sport and leisure activities; 4 questions on quality of life.

    It includes 5 sub-scores, one sub-score per domain.

  3. Forgotten Joint Score

    Time frame: 2 years

    The Forgotten Joint Score (FJS-12) is a self-administered questionnaire consisting of 12 questions assessing the degree of forgetfulness of hip replacements in a given situation of daily life. Each answer is selected from a 5-point Likert scale with response options ranging from never (0) to most of the time (4).

  4. Prosthesis life span

    Time frame: 2 years

    The life span of the prosthesis is the time between the implantation of the prosthesis and its complete or partial surgical revision.

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: ATHENS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 20, 2021
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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